- Clear that Cabinet Tour ‘24 April 18, 2024
- The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation” April 17, 2024
- Does the Drug Shortage White Paper Fall Short? April 9, 2024
- OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality Efforts April 8, 2024
- FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah) April 3, 2024
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President Bush Signs FDA Amendments Act
September 27, 2007Earlier today, the White House announced that President Bush signed H.R. 3580, the FDA Amendments Act of 2007, into law. The U.S. Department of Health and Human Services subsequently issued an announcement praising the new law as "an important step forward in ensuring the safety of drugs and medical devices." A copy of the enrolled bill sent to the President is available here. A copy of the public law, as well as FDA’s PDUFA IV "goals documents" (and perhaps the Fiscal Year 2008 user fee rates), should be available shortly. Any signing statement that might accompany the new law will be available in the Weekly Compilation of Presidential Documents.
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- Clear that Cabinet Tour ‘24 April 18, 2024
- The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation” April 17, 2024
- Does the Drug Shortage White Paper Fall Short? April 9, 2024
- OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality Efforts April 8, 2024
- FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah) April 3, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized